Head Of Group Medical Regulatory

3 mesi fa

Ne, Italia Luxottica A tempo pieno

WHO WE AREWe are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses. The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that is uniquely positioned to address the world's evolving vision needs and the global demand of a growing eyewear industry. With over 180,000 dedicated employees in 150 countries driving our iconic brands, our people are creative, entrepreneurial and celebrated for their unique perspectives and individuality. Committed to vision, we enable people to "see more and be more" thanks to our innovative designs and lens technologies, exceptional quality and cutting-edge processing methods. Every day we impact the lives of millions by changing the way people see the world.ENVISION YOUR FUTURE JOB:We are looking for a profile of Head Of Medical Regulatory that will be based in our HQ Operations - Agordo (BL).The position reports within the Group Quality Team, working cross-functionally with the different Company Departments in order to ensure the Group full compliance with Medical Devices Applicable Regulations at a Global Level. The perfect fitting candidate has ideally a previous experience in QARA environment with a particular focus on Regulatory aspects and Medical Devices topics.
Primary responsibility of the role is to be updated on MD Regulatory scenarios at Global Level, set Regulatory Company guidelines, support the Business through specific regulatory related position papers and clear technical recommendations. The selected candidate will even cover the PRRC role for the Group.AREAS OF RESPONSIBILITIES AND RELATED ACTIVITIES:• Manage and lead the Regulatory Status at Global level for Medical Devices topics and with a specific focus on MDR.• Oversee the implementation and maintenance of policies and procedures related to quality management and control, including document control, change control, risk management.• Monitor and evaluate the effectiveness of the QMS through metrics and internal audit, with specific focus on Medical.• Ensure compliance with applicable regulatory requirements and quality standards, working transversally with all the Company Departments.• Provide leadership and guidance to the Quality Systems team and cross-functional teams to ensure quality objectives are met and maintained.• Ensure compliance with all applicable laws, regulations, and industry standards related to Medical Devices.
• Collaborate with Legal, R&D, Engineering and Manufacturing, and other departments to ensure quality requirements are incorporated into product development, production, and post-market activities.• Participate in regulatory inspections and support resolution of any quality-related issues.• Check the conformity of devices/products in accordance with the quality management system (QMS) the company uses before the device/product is released.• Ensure that technical documentation and the EU documentation of conformity are generated and up to date.• Make sure the company complies with post market surveillance obligations working with the Head of Market Technical Excellence (Article 10(10) of MDR).• Be responsible for ensuring that the company fulfills its reporting obligations, found in Articles 87-91 of MDR.• Manage, when needed, relationship and activities with Notified Bodies.• Ontop of the role above described, the Head of Group Medical Regulatory will facilitate the integration of the GV Quality related activities leading the change in the organization.NETWORK OF INTERACTION:
INTERNAL : Quality, Legal, R&D, Engineering, Manufacturing
EXTERNAL : External entities responsible for the Medical Regulatory, Retail and Wholesale teams.TECHNICAL SKILLS - PORTRAIT OF A PERFECT CANDIDATE:
• Educational Background in Engineering.
• At least 4/5 years of experience in Quality Departments• Strong problem solving skills and fluency in English• Solid experience in QARA environment with a particular focus on Regulatory aspects and Medical Devices topics.WHAT ELSE DO YOU NEED TO KNOW?In EssilorLuxottica you have the feeling of being part of a "success story", no matter where you work in the EssilorLuxottica world, you can really make an impact.Are you ready for this challenge?If yes, we are waiting for you.

  • Head Of Group Medical Regulatory

    2 mesi fa

    Ne, Italia Operations Oo A tempo pieno

    WHO WE ARE We are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses. The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that...

  • Head Of Group Medical Regulatory

    2 mesi fa

    Ne, Italia Operations Oo A tempo pieno

    WHO WE ARE We are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses.The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that is...

  • Regulatory Affairs Manager

    1 mese fa

    Ne, Italia Essilorluxottica Group A tempo pieno

    WHO WE ARE   We are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses.The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that...

  • Regulatory Affairs Manager

    4 settimane fa

    Ne, Italia Essilorluxottica Group A tempo pieno

    WHO WE ARE   We are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses.The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that...

  • Regulatory Affairs Manager

    1 mese fa

    Ne, Italia Operations Oo A tempo pieno

    WHO WE AREWe are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses.The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that is...

  • Regulatory Affairs Manager

    1 mese fa

    Ne, Italia Operations Oo A tempo pieno

    WHO WE ARE We are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses. The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that...

  • Head Of Hr

    2 settimane fa

    Ne, Italia Prtnr Recruiting A tempo pieno

    Head of HRRelocation to Northern Italy, only apply if you can relocate.Must come from Fashion or Electronics Brands like LG, SAMSUNG, etc.The Head of HR is a highly visible hands-on position driving people-centered functional excellence and process improvement.This role is critical in the management of our people initiatives including leadership and...

  • Head Of Hr

    3 settimane fa

    Ne, Italia Prtnrrecruiting A tempo pieno

    Head of HRRelocation to Northern Italy, only apply if you can relocate.Must come from Fashion or Electronics Brands like LG, SAMSUNG etc.The Head of HR is a highly visible hands-on position driving people-centered functional excellence and process improvement.This role is critical in the management of our people initiatives including leadership and coaching,...

  • Head Of Hr

    4 settimane fa

    Ne, Italia Prtnrrecruiting A tempo pieno

    Head of HR Relocation to Northern Italy, only apply if you can relocate. Must come from Fashion or Electronics Brands like LG, SAMSUNG etc. The Head of HR is a highly visible hands-on position driving people-centered functional excellence and process improvement. This role is critical in the management of our people initiatives including leadership and...

  • Group Service Director

    3 settimane fa

    Ne, Italia Mercuri Urval Srl A tempo pieno

    Il Group Service Director, riportando al Group Chief Sales & Marketing Officer, avrà la piena responsabilità di implementare le linee guide delle attività di service a livello globale, in modo da incrementare il fatturato relativo al post vendita e l'efficienza delle attività dei centri di assistenza tecnica (CAT). Coordinerà a livello gerarchico il...

  • Regulatory Affairs

    2 giorni fa

    Ne, Italia Lavoropiù A tempo pieno

    Farmapiù, divisionespecialistica del gruppo Lavoropiù, cerca un/a Regulatory AffairsJunior - RA Specialist - Addetto/a agli affari regolatori per aziendadel settore biomedicale con ottima conoscenza del nuovo MDR e dellaISO 13485 e padronanza della lingua inglese per inserimento stabilein organico.La risorsa curer : Gestione fascicolitecnici, analisi dei...

  • Quality & Compliance Smart Eyewear Intern

    3 mesi fa

    Ne, Italia Essilorluxottica Group A tempo pieno

    WHO WE ARE We are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses. The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that...

  • Head Of Data Ytics

    1 settimana fa

    Ne, Italia Decorating Interior A tempo pieno

    Data ysis is critical in interpreting complex data to help businesses make informed decisions.With the advent of big data, the demand for sed data ysts has surged across various industries.Here's a detailed exploration of the data yst job, including what data ysis entails, the role of a data yst, their importance, the top data yst ss and more.Key Takeaways:...

  • Software Validation Engineer

    2 mesi fa

    Ne, Italia Steelco S.P.A A tempo pieno

    Validation engineers evaluate systems and processes used to build products. They work in several fields, such as pharmaceuticals, biotechnology, or medical devices, among others.Validation engineers ensure products meet company requirements. They run software tests and analyze and document results. Validation engineers monitor compliance with safety and...

  • Software Validation Engineer

    2 mesi fa

    Ne, Italia Steelco S.P.A A tempo pieno

    Validation engineers evaluate systems and processes used to build products.They work in several fields, such as pharmaceuticals, biotechnology, or medical devices, among others.Validation engineers ensure products meet company requirements.They run software tests and analyze and document results.Validation engineers monitor compliance with safety and quality...

  • Group Logistics Internship

    3 mesi fa

    Ne, Italia Essilorluxottica Group A tempo pieno

    WHO WE ARE We are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses.The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that is...

  • Autista Tecnico Esterno Addetto Alle Consegne

    3 settimane fa

    Ne, Italia Gi Group S.P.A A tempo pieno

    Gi Group, prima Agenzia per il Lavoro Italiana con oltre 200 filiali sul territorio nazionale e più di 1800 professionisti nel settore delle Risorse Umane, ricerca per struttura ambito medicale:AUTISTA TECNICO ESTERNO ADDETTO ALLE CONSEGNE - SETTORE MEDICALELa persona, in accordo con il personale della struttura, dovrà secondo le normative consegnare...

  • Design Assurance Engineer

    2 settimane fa

    Ne, Italia Orthofix A tempo pieno

    We are looking for a Design Assurance Engineer, to join our Quality Regulatory Department, based in Bussolengo (Verona).Position Summary: The role is the liaison between Research Development (RD), Process Engineering and Quality Operation areas, and Regulatory Affairs area, during the Design Development of new products and during business as usual with the...

  • Design Assurance Engineer

    2 mesi fa

    Ne, Italia Orthofix A tempo pieno

    We are looking for a Design Assurance Engineer, to join our Quality & Regulatory Department, based in Bussolengo (Verona).Position Summary: The role is the liaison between Research & Development (R&D), Process Engineering and Quality Operation areas, and Regulatory Affairs area, during the Design & Development of new products and during business as usual...

  • Operaio Addetto Sanificazione-Settore Medicale

    2 settimane fa

    Ne, Italia Gi Group S.P.A A tempo pieno

    GiGroup agenzia per il lavoro di Verona ricerca per nota azienda del settore medicale:OPERAIO ADDETTO ALLA SANIFICAZIONE SETTORE MEDICALE-CONFEZIONAMENTO SISTEMI ANTIDECUBITO-La persona dovrà prestare servizio per la sanificazione di materiali medicali, in particolar modo di materassi per strutture ospedaliere. Si richiede quindi personale in grado di...